SUPERBRAIN: Multidomain Interventions Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment

Sponsor

Inha University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05023057

Collaborator

(none)

300

Enrollment

Locations

Arms

21.2

Anticipated Duration (Months)

42.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will be done to investigate the effectiveness of a 24-week multidomain intervention program consisting of cognitive training, exercise, nutrition management, vascular disease risk factor management, social activity, and motivational enhancement on the cognitive function compared to the control group in mild cognitive impairment.

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment	Behavioral: Multidomain intervention	N/A

Detailed Description

The physical exercise program will consist of aerobic exercise, exercise to enhance balance and flexibility, muscle-strengthening activities involving major muscle groups, and finger-toe movements. Cognitive training targets the cognitive domains of episodic memory, executive function, attention, working memory, calculation, and visuospatial function. Cognitive training will be conducted using a tablet-based application. Participants will be advised to eat something according to the recommendation of the MIND diet. They will also meet the study nurse every 4 weeks for anthropometric measurements and monitoring of smoking and alcohol intake. The purpose of the motivational enhancement program is to induce, maintain, and strengthen motivation, which is a psychological resource to help maintain dementia prevention activities.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

outcome assessor-blinded, randomized controlled trialoutcome assessor-blinded, randomized controlled trial

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

A Multicenter Randomized Controlled Study to Evaluate the Efficacy of a 24-week Multidomain Intervention Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment

Actual Study Start Date :

Sep 23, 2021

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Multidomain intervention The participants in the intervention arm will receive all five components of the intervention: (1) monitoring and management of metabolic and vascular risk factors; (2) cognitive training and social activity; (3) physical exercise; (4) nutritional guidance; and (5) motivational training.	Behavioral: Multidomain intervention For 24 weeks, participants will receive cognitive training using the tablet PC application twice a week, exercise 3 times a week, nutrition education 12 times, anthropometric measurements and alcohol and smoking monitoring every 4 weeks, motivation reinforcement training 4 times.
No Intervention: Control At baseline, the participants in the control group will meet a study doctor, be prescribed medication when necessary, and receive educational booklets corresponding to their risk factors and a booklet on lifestyle guidelines to prevent dementia. They will receive usual care during the study period and be informed that they could participate in the multidomain intervention program after this study end.

Arm

Intervention/Treatment

Experimental: Multidomain intervention

The participants in the intervention arm will receive all five components of the intervention: (1) monitoring and management of metabolic and vascular risk factors; (2) cognitive training and social activity; (3) physical exercise; (4) nutritional guidance; and (5) motivational training.

Behavioral: Multidomain intervention

For 24 weeks, participants will receive cognitive training using the tablet PC application twice a week, exercise 3 times a week, nutrition education 12 times, anthropometric measurements and alcohol and smoking monitoring every 4 weeks, motivation reinforcement training 4 times.

No Intervention: Control

At baseline, the participants in the control group will meet a study doctor, be prescribed medication when necessary, and receive educational booklets corresponding to their risk factors and a booklet on lifestyle guidelines to prevent dementia. They will receive usual care during the study period and be informed that they could participate in the multidomain intervention program after this study end.

Outcome Measures

Primary Outcome Measures

Change of cognition [Change from Baseline at 24 weeks]
Repeatable Battery for the Assessment of Neuropsychological Status (range 40-160). Higher scores indicate better performance.

Secondary Outcome Measures

Change of global cognition [Change from Baseline at 24 weeks]
Mini-Mental State Examination (range 0-30). Higher scores indicate better performance.
Change of function [Change from Baseline at 24 weeks]
Clinical Dementia Rating scale-Sum of Boxes (range 0-18). Higher scores indicate worse performance.
Change of subjective memory [Change from Baseline at 24 weeks]
Prospective and Retrospective Memory Questionnaire (range 16-80). Higher scores indicate worse performance.
Change of depression [Change from Baseline at 24 weeks]
Geriatric Depression Scale-15 items (range 0-15). Higher scores indicate worse performance.
Change of quality of life [Change from Baseline at 24 weeks]
Quality of life-Alzheimer's disease (range 0-52). Higher scores indicate better performance.
Change of activities of daily living [Change from Baseline at 24 weeks]
Bayer Activities of Daily Living (range 1-10). Higher scores indicate worse performance.
Change of nutritional behavior [Change from Baseline at 24 weeks]
Nutrition Quotient for elderly (range 0-100). Higher scores indicate better performance.
Change of nutrition [Change from Baseline at 24 weeks]
Mini Nutritional Assessment (range 0-14). Higher scores indicate better performance.
Change of motor function [Change from Baseline at 24 weeks]
Short Physical Performance Battery (range 0-12). Higher scores indicate better performance.
Change of sleep quality [Change from Baseline at 24 weeks]
Pittsburgh Sleep Quality Index (range 0-21). Higher scores indicate worse performance.
Change of motivation [Change from Baseline at 24 weeks. Higher scores indicate better performance.]
Self Determination Index (SDI). Higher scores of SDI indicate better performance.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

60 to 79 years of age
Having at least one modifiable dementia risk factor
Complaints of cognitive decline by a participant or informant
A performance score that is lower than 1.0 standard deviations below the age-, and education-adjusted normative means for one or more of the delayed recall, naming, visuoconstruction, attention, and executive function tests
MMSE Z score ≥ - 1.5
Independent activities of daily living
Being able to use the tablet PC through education, or having a person who can help a participant use the tablet PC.
Having a reliable informant who could provide investigators with the requested information
Provide written informed consent

Exclusion Criteria:

Major psychiatric illness such as major depressive disorders
Dementia
Other neurodegenerative disease (e.g., Parkinson's disease)
Malignancy within 5 years
Cardiac stent or revascularization within 1 year
Serious or unstable symptomatic cardiovascular disease
Other serious or unstable medical disease such as acute or severe asthma, active gastric ulcer, severe liver disease, or severe renal disease
Severe loss of vision, hearing, or communicative disability
Any conditions preventing cooperation as judged by the study physician
Significant laboratory abnormality that may result in cognitive impairment
Illiteracy
Unable to participate in exercise program safely
Coincident participation in any other intervention trial

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Dong-A University Hospital	Busan	Korea, Republic of
2	Chonnam University Hospital	Gwangju	Korea, Republic of
3	Inha University Hospital	Incheon	Korea, Republic of	22332
4	Bobath Memorial Hospital	Seongnam	Korea, Republic of
5	Ewha Womans Seoul Hospital	Seoul	Korea, Republic of
6	Konkuk University Hospital	Seoul	Korea, Republic of
7	Ajou University Hospital	Suwon	Korea, Republic of

Sponsors and Collaborators

Inha University Hospital

Investigators

Principal Investigator: Seong Hye Choi, MD, PhD, Inha University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seong Hye Choi, MD, Professor, Inha University Hospital

ClinicalTrials.gov Identifier:

NCT05023057

Other Study ID Numbers:

2021-06-040

First Posted:

Aug 26, 2021

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cognitive Dysfunction

Study Results

No Results Posted as of Mar 31, 2022